A common process in the molecular diagnostic laboratory is the generation of gel results. Gels are typically used to analyze deoxyribonucleic acid (DNA), ribonucleic acid (RNA) and protein results, although they may also be used to analyze other biological molecules such as lipids, oligosaccharides, and the like. A gel is a viscous substance, typically agarose or acrylamide, having a plurality of recessed portions, commonly known as wells, into which various samples may be loaded for analysis. Subsequent to loading, an electric current may be applied to the gel, pulling charged molecules of the samples through the gel. When the current has ceased, the position of the molecules relative to one another may provide useful information about various attributes, e.g., charge and/or size, of the molecule or molecules being examined, presence or absence of mutations and gene rearrangements. The information derived from the gel results may then be used to make an array of diagnostic decisions.
After a gel has been run (i.e., after the current has ceased), a substantially linear region results from each loaded well. The linear regions are commonly referred to as lanes. Due to, for instance, efficiency concerns, a plurality of samples are generally run on a single gel and, thus, a plurality of lanes results when the gel is run. In a clinical setting, this commonly results in a single gel including lanes having results from more than one individual. Additionally, one or more reference lanes are typically run on each gel. The reference lanes may include, for example, molecular weight markers and/or positive and negative controls.
Long-term management of a gel typically involves capturing and storing an image (e.g., a photographic image) of the gel rather than maintaining the gel itself. Traditional gel image management, designed primarily to meet the needs of the research community, focuses on storing an image of the entire gel. However, in a clinical setting, storing an image of an entire gel, which often includes data from a plurality of individuals, presents a significant privacy concern. For example, suppose five individuals visit an AIDS clinic on the same day to determine whether or not they are HIV+. Each of the five individuals is seated in the waiting room at the same time. Samples from each individual are loaded into a single gel and the gel is run resulting in one lane for each individual. Now suppose that although a particular one of those five individuals receives the news that she is not HIV+, she wishes to view the test results herself. Since an image of that individual's test results is a complete gel image including the lanes from the other four individuals in the waiting room, she retrieves not only her own results but those of the other four individuals as well. If the results indicate that one of the individuals tested is HIV+, even though that person's identity is not specifically set forth on the gel image, the individual in possession of the gel image would easily be able to deduce that one of the other four individuals in the waiting room is HIV+. Such disclosure of another individual's test results, though inadvertent, is clearly undesirable.
Additionally, in the clinical setting, current association of a gel image with an individual's medical record is achieved by paper-based means. That is, a photocopy of the entire gel image is physically placed in the paper record of each individual having results shown on the image. However, modern clinical information systems manage the medical records of many individuals in electronic form. Since the gel image is a paper copy while much of the remainder of the medical record is electronic, the only means by which the gel image may be associated with the electronic record is via a reference placed in the electronic record indicating that the person inquiring about the test results must access the paper record. This is clearly an inefficient and inconvenient approach.
In view of the above, the inventors hereof have recognized that a method of integrating gel image results into an individual's medical record in a manner that conveys the appropriate clinical information to the healthcare provider while protecting the privacy of the other individuals whose results are represented on the gel image would be desirable. Additionally, a means for electronic association of one or more portions of a diagnostic image with one or more individual's electronic records would be advantageous.